Celsion Reports Data Safety Monitoring Board Recommendation to Continue Dosing Patients in the Phase II Portion of the OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer
OVATION 2 Study is 50% Enrolled; Excellent R0 Surgical Resection Noted
Novel Gene-Mediated Immunotherapy is Safe and Demonstrates an Acceptable Risk/Benefit When Administered Over a Six-Month Period with Up to 17 Doses
The OVATION 2 Study combines GEN-1, the Company's IL-12 gene-mediated immunotherapy, with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the cancer as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor.
The OVATION 2 Study is designed with an 80% confidence interval for an observed Progression Free Survival (PFS)
The Company also announced that more than 50% of the projected 110 patients have been enrolled in the OVATION 2 Study. Interim clinical data from the first 36 patients who have undergone interval debulking surgery are as follows:
- Of the 36 patients who have undergone interval debulking surgery in the OVATION 2 Study:
- 20 patients were treated with GEN-1 at a dose of 100 mg/m² plus NACT, with 16 out of 20 patients (80%) having a complete tumor resection (R0), which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed; and
- 16 patients were treated with NACT only, with 9 out of 16 patients (56%) having R0 resections.
- When combining these results with the surgical resection rates observed in the Company’s prior Phase Ib dose-escalation trial (the OVATION 1 Study), a population of patients with inclusion criteria identical to the OVATION 2 Study, the data reflect the strong dose-dependent efficacy of adding GEN-1 to NACT:
|% Patients with R0 Resections|
|0, 36, 47 mg/m² of GEN-1 plus NACT||n=22||50||%|
|61, 79, 100 mg/m² of GEN-1 plus NACT||n=28||82||%
- The objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria for the 16 patients treated with NACT only were comparable, as expected, to the 20 patients treated with GEN-1 at a dose of 100 mg/m² plus NACT, with both groups demonstrating an approximate 80% ORR.
“These findings show a consistent dose-dependent clinical response in both surgical outcome and tumor response, which is further supported by translational data of the tumor microenvironment,” noted
“We thank the DSMB members for their work and advice,” said
About GEN-1 Immunotherapy
GEN-1, designed using
About Celsion Corporation
|Celsion Investor Contact
|LHA Investor Relations
# # #
Source: Celsion CORP